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Lead Quality Assurance Strategist

2 months ago

Pennsylvania, United States EPM Scientific Full time

Key Responsibilities:

  • Oversee the quality assurance processes for analytical method validations.
  • Ensure quality compliance for product release and stability assessments.
  • Manage Contract Manufacturing Organizations (CMOs) and Contract Laboratory Organizations (CLOs) to adhere to regulatory requirements and internal quality agreements.
  • Collaborate with CMOs/CLOs to maintain compliance with established quality systems.
  • Accountable for the quality standards and operational compliance of CMOs/CLOs.
  • Ensure the quality of products produced, released, and tested at CMOs/CLOs.
  • Set performance targets for CMOs and ensure they are achieved.
  • Address cGMP deviations and investigations, ensuring that corrective and preventive actions (CAPAs) are effectively implemented.
  • Evaluate change requests from CMOs and contribute to the design, development, and enhancement of quality assurance systems and programs.
  • Lead or engage in cross-functional project teams to meet quality and business objectives.

Qualifications:

  • Bachelor's degree or higher.
  • At least 10 years of experience in quality assurance.
  • Strong knowledge of Good Manufacturing Practice (GMP) regulations.
  • Experience overseeing quality assurance for analytical methods.
  • Familiarity with quality systems, particularly in the creation and revision of Standard Operating Procedures (SOPs).
  • Exceptional written and verbal communication skills, with a proven ability to effectively engage in a team environment and across various functional areas.
  • Innovative problem-solving abilities and skills in influencing peers.
  • Knowledge of biologics product testing and ICH guidelines for analytical methods is advantageous.

Contract Details:

  • Contract Length: 12 months
  • Full-time position
  • W2 employment only